Latent Tuberculosis Infection in Bone Marrow Transplant Recipients
This study is ongoing, but not recruiting participants.
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01021124
First received: November 25, 2009
Last updated: May 14, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 25, 2009 | ||||
| Last Updated Date | May 14, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
development of tuberculosis [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
development of tuberculosis [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01021124 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
all cause mortality [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
all cause mortality [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Latent Tuberculosis Infection in Bone Marrow Transplant Recipients | ||||
| Official Title ICMJE | A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients | ||||
| Brief Summary | The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation. |
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| Detailed Description | All adult bone marrow transplant recipients admitted to Asan Medical Center will be enrolled. Quantiferon-Gold In-Tube assay will be performed. Isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary TB patient or inadequate treatment history with abnormal CXR). However, isoniazid prophylaxis will be not given based on positive TST or positive Quantiferon-Gold In-Tube assay. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: whole blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Bone marrow transplant recipients |
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| Condition ICMJE | Tuberculosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | QFT (+) vs QFT (-) | ||||
| Publications * | Moon SM, Lee SO, Choi SH, Kim YS, Woo JH, Yoon DH, Suh C, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. Comparison of the QuantiFERON-TB Gold In-Tube test with the tuberculin skin test for detecting latent tuberculosis infection prior to hematopoietic stem cell transplantation. Transpl Infect Dis. 2013 Feb;15(1):104-9. doi: 10.1111/j.1399-3062.2012.00765.x. Epub 2012 Jul 23. PubMed PMID: 22823749. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 409 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01021124 | ||||
| Other Study ID Numbers ICMJE | 2009-0077 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sung-Han Kim, Asan Medical Center | ||||
| Study Sponsor ICMJE | Asan Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asan Medical Center | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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